Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.

Official Title

A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Keywords

Geographic Atrophy, Macular Degeneration, Atrophy, Prednisone, Triamcinolone, JNJ-81201887

Eligibility

You can join if…

Open to people ages 60 years and up

  • Have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an area that can be measured and measures 2.5 millimeter square (mm2) to 17.5 mm2 (1-and 7- disc areas respectively), determined by the central reading center (CRC) from screening images of fundus autofluorescence (FAF) and spectral domain optical coherence tomography (SD-OCT)
  • If GA is multifocal, at least one focal lesion must be greater than or equal to (>=) 1.25 mm2 (0.5- disc area), as assessed by the CRC
  • GA can be photographed in its entirety by FAF, using a 30- degree image centered on the fovea, as assessed by the CRC
  • Fellow eye must be present with a best corrected distance visual acuity (BCVA) of counting fingers or better
  • Man or woman (according to their reproductive organs and functions assigned by chromosomal complement)

You CAN'T join if...

  • History of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye
  • Any prior thermal laser in the macular region, regardless of indication
  • History of retinal detachment (with or without repair)
  • Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
  • Any sign of diabetic retinopathy or central serous chorioretinopathy

Locations

  • Jules Stein Eye Institute UCLA
    Los Angeles California 90095 United States
  • Shiley Eye Institute Jacobs Retina Center
    La Jolla California 92093 0946 United States
  • The Retina Partners
    Los Angeles California 91436 United States
  • Retina Associates Of Southern California
    Huntington Beach California 92647 United States
  • Retina Consultants San Diego
    Poway California 92064 United States
  • Retina Consultants of Orange County
    Fullerton California 92835 United States
  • California Eye Medical Specialists
    Pasadena California 91107 United States
  • Bay Area Retina Associates
    Walnut Creek California 94598 United States
  • Stanford Health Care
    Palo Alto California 94303 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05811351
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 305 people participating
Last Updated